CCB Project - Pills Free Baltic

Pills Free Baltic

2017-2018

CCB express its deep concern about the threat posed by pharmaceuticals in the environment to citizens and the environment. Even low concentrations of pharmaceuticals in the environment can have far-reaching effects on ecosystems – causing reproductive failure, growth inhibition, behavioural changes, and species’ population collapse.

OVERVIEW OF THE ISSUE

Pharmaceuticals in the environment are a global problem – more than 600 pharmaceuticals and their metabolites have been found in the environment worldwide. Active pharmaceutical ingredient molecules are mostly very stable and have a high persistence for biodegradation.

They enter the environment (through water, soil, sludge, and organisms) at all stages of their life cycle and can end up in drinking water, and accumulate in fish, vegetables, and livestock.

"PILLS FREE BALTIC" IN A NUTSHELL

Pharmaceutical production and healthcare facilities are the so called “hotspots”. Their sewage is not subject to special requirements concerning the concentration of pharmaceuticals or sewage treatment technologies. A selective elimination of trace elements of active pharmaceuticals ingredients is not possible in conventional WWTPs. By now none of the BSR-countries introduced mandatory requirement to the monitoring of APIs concentrations in the sewage waters. Transformation of APIs does not always mean that detoxification occurs, as there are examples where transformation products are more toxic and abundant than the parent compounds.

The consumption phase is considered to be the biggest contributor to the emissions of pharmaceuticals into the environment, mainly through excretions and incorrect disposal of unused medicines into sinks and toilets. Between 30 to 90% of the orally administered dose is generally excreted as active substance in the urine of humans and animals, with the nature and amount of medicinal residues mainly dependent on the volumes and nature of the administered substances, the mode of administration and metabolization rates.

Mishandling of unused pharmaceuticals may be regarded as the second largest source of their getting into the environment after the emissions of pharmaceuticals into the environment through excretions. Proper collection and disposal of household pharmaceutical waste can contribute to reducing the impact of pharmaceuticals on the environment. Effective collection schemes would divert unused medicines from mixed waste streams that are not designed to deal specifically with pharmaceutical products.

The problem of veterinary medicinal products occurrence in the environment is currently under investigation. Much consideration is given to the processes of excretion and transformation of veterinary pharmaceuticals after their consumption by the animals. Livestock farms and fish farms turn up to be hotspots for the entry of pharmaceuticals into the environment.

Useful reading on the topic:

Pharmaceuticals in the aquatic environment of the Baltic Sea region (status report)

Pharmaceuticals and their residues that enter the water supply and spread to surface waters and agricultural lands can ultimately end up in drinking water and build up in vegetables and fish. Transformation of APIs does not always mean that detoxification occurs, as there are examples where transformation products are more toxic and abundant than the parent compounds

Pharmaceuticals are designed to have specific biological effects and biological persistency; hence the risk of bioaccumulation and effects in non-target organisms. The widespread occurrence of medicinal products in the environment is well documented today, but our present understanding of the extent of the problem is fragmented and ma ny knowledge gaps still remain.

Animals and other organisms that are exposed to pharmaceuticals in water, soil, or even by feeding on medicated animals can experience behavioural, physiological, and histological effects.

One of the worst cases of wildlife poisoning by a chemical has been attributed to a pharmaceutical product: Diclofenac. This anti-inflammatory non-steroidal drug (NSAID), caused a 97% decline in 3 species of Old World vultures (genus Gyps) in Asia, with risk of extinction. Vultures feeding on carcasses of cattle treated with diclofenac suffered acute kidney failure and died within days.

Pharmaceuticals in the environment may also pose a concern to human health. Although the concentrations of pharmaceuticals may be low, exposure to mixtures of pharmaceuticals with other chemicals could pose a risk to human health. Synergistic effects can intensify therapeutic properties and even low concentrations can be dangerous to people for whom a medicine has been contraindicated.

Antibiotics in the environment can promote the development of antibiotic-resistant pathogens.

Useful reading on the topic:

Information on the environmental effects of pharmaceuticals

System of ecological classification of medicines in Sweden

Study on the environmental risks of medicinal products. BIO Intelligence Service. 2013

Background report on pharmaceutical concentrations and effects in the Baltic Sea. SWECO ENVIRONMENT AB. 2015

Pharmaceutical pollution is addressed peripherally in certain EU legislation such as the Directive on medicine for human use and the Water Framework Directive.

By 13 September 2015, the European Commission will create a strategic approach to the pollution of water by pharmaceutical substances “which will include proposals enabling, to the extent necessary, the environmental impacts of medicines to be taken into account more effectively in the procedure for placing medicinal products on the market.”

Appropriate changes at the legislative level: develop limits and/or thresholds for APIs in different environmental areas and in drinking water; include APIs in environmental legislation; establish a more restrictive connection between environmental properties and the authorization of human pharmaceuticals; improve legislation for the management of outdated medicaments; establish incentives for the development of greener drugs; establish a country-adapted classification system for pharmaceuticals

The Waste Framework Directive states that Member States can take legislative or nonlegislative action to extend producer responsibility, including “an acceptance of returned products and of the waste that remains after these products have been used, as well as the subsequent management of the waste and financial responsibility for such activities”.

The “polluter pays” principle should be implemented with respect to the pharmaceutical waste, and the costs associated with the collection schemes and awareness campaigns should be borne by the pharmaceutical industry and its distributors.

The requirement for the EU member-states to implement collection schemes for unused pharmaceutical products was introduced by Directive 2004/27/EC (relating to medicinal products for human use).

Useful reading on the topic:

20 Organisations sign declaration expressing serious concern about pharmaceuticals in the environment in the EU

HCWH Europe Recommendations on pharmaceuticals in the environment – September 2016